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Investigation Specialist
2 months ago
Onsite Investigation Specialist
Trinity Consultants - Advent Engineering is a prominent engineering and consulting organization dedicated to delivering specialized services to the pharmaceutical and biotechnology sectors. With a strong presence across various regions, our firm engages in comprehensive aspects of global pharmaceutical and biotechnology facility design, process engineering, and quality system initiatives.
Our expertise encompasses process engineering, automation engineering, project management, facility/system design, startup and commissioning, validation, and compliance consulting for leading biotechnology and pharmaceutical manufacturing enterprises.
The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of diverse processes, systems, and facilities. A blend of robust technical skills, automation engineering proficiency, and technical documentation capabilities are essential for this role.
Key Responsibilities:
- Conducting, leading, and managing comprehensive investigations.
- Performing fact-finding, assessment, and root cause analysis (RCA), developing corrective and preventive actions (CAPAs), and coordinating cross-functional teams.
- Demonstrating a strong understanding of cGMP biopharmaceutical manufacturing processes, including upstream and downstream processes, with knowledge of UF/DF systems, chromatography, bioreactors, seed train, and disposable technologies.
- Exhibiting a high level of knowledge in metrology, maintenance systems, preventative maintenance, HVAC, WFI, clean steam, and compressed air pharmaceutical systems.
- Responsible for the creation and monitoring of performance metrics.
- Staying informed about current good manufacturing practices (cGXPs).
Qualifications:
- Possessing a minimum of a BS/BA in a scientific or engineering discipline with over 3 years of relevant experience in investigations and cGMP manufacturing operations.
Skills and Attributes:
- Understanding of drug product manufacturing from formulation to final packaging.
- Familiarity with regulatory compliance, including cGMP, FDA regulations, and knowledge of ICH guidelines and EU regulations.
- Proficient in Microsoft Office Suite, including Excel, PowerPoint, Visio, Word, and SharePoint, with experience in collaborative work environments.
- Strong interpersonal, written, and verbal communication skills.
- Exhibiting confidence, high emotional intelligence, and the ability to provide team updates effectively.
- Demonstrating resilience and adaptability in challenging situations and tight deadlines.
- Listening to team members and stakeholders to foster a productive team environment towards shared objectives.
